Biotechnology Hearing Surfaces Oversight Gaps, Tradeoffs

The National Security Commission on Emerging Biotechnology released an analysis and 83 policy options on January 13 intended to streamline the regulatory process and unleash the potential of emerging biotechnologies. That same month, Senator Bill Cassidy (R-LA), chairman of the Senate Health, Education, Labor, and Pensions Committee, published a report on regulatory reform and proposals to modernize the FDA, with stated goals of maintaining American biomedical dominance and ensuring patients have timely access to lifesaving treatments.

Congress has held multiple hearings on biosecurity over the past decade, examining gain-of-function research oversight, dual-use research of concern, national biodefense strategy, biodefense preparedness, pandemic origins, and bioterrorism vulnerability.

What They're Saying

Rep. Rich McCormick (R-GA-7), who chairs the subcommittee, opened by framing biotechnology as central to national security and economic competition. "The Chinese Communist Party has made biotechnology a national priority," McCormick said, comparing Beijing's coordinated effort to its push in semiconductors and artificial intelligence. He noted that the United States had led the world in biotechnology for decades, producing vaccines, therapeutics, innovations, and economic growth, and that biotechnology leadership would provide advantages in medicine, agriculture, industry, and defense.

McCormick highlighted a key concern: whether existing oversight mechanisms are adequate. He pointed to federally funded research involving the Wuhan Institute of Virology and EcoHealth Alliance as raising questions about the effectiveness of the existing oversight system. The federal government paused funding for certain gain-of-function research in 2014 while evaluating its risks and benefits. The Department of Health and Human Services established the P3CO framework in 2017 as a case-by-case review process.

Rep. Emilia Strong Sykes (D-OH-13) highlighted the economic stakes. Recent estimates put the U.S. biotechnology sector's employment at more than 600,000 jobs and its annual contribution to national GDP at more than $200 billion. An Ohio life sciences survey found that the industry employed nearly 65,000 people.

But Sykes raised a critical challenge to the administration's approach. The administration terminated dozens of research grants in summer 2025, allegedly over gain-of-function concerns, including grants involving tuberculosis research. Sykes noted that scientists, universities, professional societies, and federal agencies had struggled with the definition of dangerous gain-of-function research. The administration issued a new policy in July 2026 to implement the executive order, but the ambiguity around what constitutes prohibited research has created uncertainty.

McCormick introduced two bills to address the policy gaps. The Biotechnology Workforce Alignment Act is intended to align federal biotechnology research investment with the workforce needed to develop and scale innovations in the United States. The Biotechnology Diplomacy Leadership Act is intended to coordinate the U.S. voice on biotechnology policy abroad and address adversaries' efforts to access American data, technology, and capabilities.

The hearing examined how artificial intelligence and biotechnology are converging to reshape opportunities and risks. McCormick noted that artificial intelligence is accelerating drug discovery, protein design, and biomanufacturing.

Three witnesses testified: Dr. Anemone Franz, a visiting research fellow at the American Enterprise Institute who focuses on biosafety and biosecurity; Joshua Hodges, a visiting fellow at the Hoover Institution; and Dr. Gigi Gronvall, a professor at Johns Hopkins University's Bloomberg School of Public Health and senior scholar at the Johns Hopkins Center for Health Security. Gronvall is an immunologist who has written extensively about synthetic biology, preparations for bioterrorism, and the contested origin of SARS-CoV-2.

Political Stakes

The Trump administration has moved quickly on biosecurity, but the hearing suggests Congress wants additional legislative tools.

For McCormick, the hearing offers an opportunity to establish himself as a serious voice on biosecurity while building legislative momentum for his two bills. For the administration, the hearing validates its biosecurity focus but also highlights implementation challenges—particularly around the ambiguous definition of gain-of-function research that has already led to grant terminations.

The sector contributes substantially to the economy and employment, but regulatory tightening and supply-chain restrictions on Chinese equipment could slow innovation and increase compliance costs. For the public, the hearing raises questions about whether the federal government can balance security with scientific progress.

The Biotechnology Innovation Organization reported $2.36 million in lobbying expenditures for the second quarter of 2026, with disclosures covering appropriations, antitrust legislation, and foreign-investment scrutiny. The hearing statement identified laboratory accidents, deliberate misuse, inadequate oversight, and release of harmful biological information or materials as biosecurity risks.

The Other Side

The tension between innovation and security is not easily resolved. While McCormick and the administration emphasize the China threat and the need for tighter oversight, Sykes's concerns about grant terminations and definitional ambiguity highlight the costs of overly broad restrictions. Scientists, universities, professional societies, and federal agencies have struggled with the definition of dangerous gain-of-function research, and the administration terminated dozens of research grants in summer 2025 allegedly because of gain-of-function concerns.

Some analyses emphasize combined or cascading risks when large language models and biological design tools are used together. Other analyses treat large language models and biological design tools as largely separate governance challenges. This disagreement contributes to debate over the appropriate scope of regulation.

Additionally, a Journal of Law and the Biosciences article assesses the International Health Regulations, the Biological Weapons Convention, UN Security Council Resolution 1540, and national biosecurity laws. The article concludes that these biosecurity instruments impose binding obligations intended to prevent the misuse of biological agents but that the terms of those instruments are outdated and the application is fragmented.

What's Next

The hearing did not appear to produce immediate legislative votes or next steps based on available records. However, McCormick's two bills—the Biotechnology Workforce Alignment Act and the Biotechnology Diplomacy Leadership Act—are now formally introduced and could advance through committee.

The administration faces a deadline under the BIOSECURE Act to designate Chinese CROs and CDMOs subject to the procurement restriction by the end of 2026. How those designations are made will signal the administration's actual enforcement posture and could shape industry behavior.

Congress may also revisit the definition of gain-of-function research to reduce ambiguity and provide clearer guidance to researchers, universities, and federal agencies. The National Security Commission on Emerging Biotechnology's 83 policy options provide a roadmap for additional legislative action.

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